Partner Perspective Presentations
Diagnostics and Biomarkers
Early Oncology Partnering forum is proud to host key players from the early-stage oncology companies and investment community from around the globe. This event will facilitate discussion and networking between early stage companies that are developing innovative products and technology and leading investors, big pharma and industry executives in an effort to build partnerships, attract investment and foster further business collaborations. Early Oncology Partnering Forum employs partnering software that will allow registered attendees to contact speakers prior to the conference and to schedule time for one-on-one meetings during the conference.
February 21-22 | Held at the InterContinental Hotel
Sunday, February 20
4:00 - 6:00 pm Pre-Registration
Monday, February 21
8:00 am Registration & Morning Coffee
This session is designed to provide a series of perspectives from companies that represent potential partners for the early stage companies showcased in the rest of the program. Each Perspective Presenter will address some of the criteria and factors that they take into consideration when considering earlier stage collaborations.
8:50 Chairperson’s Opening Remarks
Phillips Kuhl, President, Cambridge Healthtech Institute
9:00 Amgen’s Perspective on Collaboration Opportunities in Oncology
Iain Dukes, M.A., D. Phil., Vice President, External R&D Affairs, Amgen
9:30 Partnering with Lilly Oncology: Go Lean-to-POC or Bring Proof-of-Revelance
John Herrmann, Ph.D., Senior Director, Global External Research and Development (Oncology), Eli Lilly & Co.
-Proof of relevance: the new threshold for partnering later stage assets
-Alternative development / deal flow channels at LLY: lean to proof-of concept through Chorus & Mirror Funds for earlier stage assets
10:00 The Independent Partner’s Perspective: QIAGEN’s Experiences with Companion Diagnostic Co-Development
David Jackson, Ph.D., Senior Director, Pharma Business Development, QIAGEN
- The companion diagnostic wish list – what Pharma look for in a diagnostic partner.
- Plotting a course to commercialization – QIAGEN’s experiences in the development and launch of the therascreen® KRAS PCR Kit and the therascreen® EGFR PCR Kit companion diagnostics for oncology.
- Looking ahead – where now for companion diagnostics? New potential therapeutic areas to explore.
10:30 Abbott’s Perspective on the Oncology Landscape and Criteria for Collaborations
Neela Patel, Ph.D., Director, External Research, West Coast, Abbott Laboratories
11:00 Merck’s Approach for Partnering in Oncology
Yael Weiss, Ph.D., Director, Licensing and External Research, West Coast, Merck & Co.
11:30 Enjoy Lunch on Your Own
12:55 pm Chairperson’s Remarks
Phillips Kuhl, President, Cambridge Healthtech Institute
1:00 Monoclonal Antibody Proteomics: Discovery of Early Markers of Lung Cancer
Laszlo Takacs, M.D., Ph.D., CSO, Biosystems International SAS (www.biosys-intl.com)
To address the imminent need for an improved proteome profiling tool, we developed a proteome-wide strategy, referred to as mAB proteomics. Due to the lack of translation bottleneck, we quickly discovered and validated an antibody panel on multiple cohorts and show over 80% accuracy in detecting early stage I lung cancer. Currently we are developing assays to commercialize a new diagnostic tool for the diagnosis of lung cancer. The new technology which is generally applicable and the discoveries in this particular case open new perspectives for the diagnosis and eventually for early detection of lung cancer, which could result in improved survival.
1:13 Early Detection and Treatment Monitoring of Breast Cancer in vivo by Fluorescence Lifetime Imaging
Guobin Ma, Ph.D., Director, Research & Development, Advanced Research Technologies, Inc. (www.art.ca)
Early detection and treatment is the best solution to increasing the survival rate of breast cancer patients. If tumor cells are detected before spreading, therapies are less invasive and more effective in eradicating the cancer. Too often, it is concluded a cancer drug is not effective. Part of the reason is that the tumor being treated is already too big. The technology provides a new way for drug developers to more precisely examine the efficacy of new drugs cost effectively. Two million MCF-7 breast cancer cells were implemented in CD-1 nude female mice. The tumor was detected in vivo by fluorescence lifetime imaging before other traditional means. When the tumor is treated by Tamoxifen, fluorescence lifetime imaging also detected the treatment efficacy earlier.
1:26 A Diagnostic Platform to Identify Panels of Biomarkers for the Diagnosis of Cancer
Will Colon, Director, Business Development, Oxford Gene Technology (OGT) (www.ogt.co.uk)
OGT has developed a “functional protein” microarray to detect autoantibodies in cancer serum samples. By identifying their cognate antigens and using cutting-edge data analysis methods, these autoantibodies can be used as biomarkers to predict disease with high accuracy. A set of biomarkers which can distinguish prostate cancer from control samples with both specificity and sensitivity above 90% has been identified using this approach. We have combined a novel proteomic platform with advanced statistical analysis (genetic programming) and applied it to studies containing statistically relevant numbers of clinical samples. We have identified novel panels of biomarkers with built-in redundancy, which perform better than any other diagnostic test for prostate cancer that we are aware of.
1:39 Zetiq’s CellDetect® Novel Cancer Diagnosis Platform Technology—Using Differential Staining to Develop a Product for Effective Early Diagnosis of Cervical Cancer
Adi Elkeles, M.B.A., Ph.D., CEO, Zetiq Technologies, Ltd. (www.zetiq.co.il)
Zetiq Technologies Ltd. has developed a unique proprietary platform CellDetect® technology for differential detection of cancer cells. After being processed using the CellDetect® Technology, cancer cells are colored red, while non-cancer cells are colored green. This color discrimination does not interfere with the morphology of the suspected cells; hence providing dual analysis of both color discrimination and morphological analysis, enabling easy detection of cancer cells with increased sensitivity and specificity. Zetiq has performed pre-clinical studies showing the potential of this unique staining tool to detect cancer cells in a variety of tissue specimens and cell lines. The company has developed products for cervical and bladder cancer diagnosis, which have achieved positive results in targeted clinical trials Zetiq's CellDetect® cervical cytology was shown to be non inferior, and to offer an overall higher sensitivity and specificity that the Pap test and the HPV test in two trials. In another pilot trial testing cervical biopsies, Zetiq has shown a 100% match to current "gold standard" method in diagnosing cervical cancer. The combined results of these clinical trials show that for cervical cancer Zetiq has complementary products able to screen as well as diagnose the disease. CellDetect® cytological cancer diagnostic applications present numerous advantages including easy detection of rare cancer cells among normal cells, enabling dual color and morphological analysis, providing a resource saving tool that is amendable to automation, offering cost effective products that can be effectively analyzed by lower skilled technicians. Zetiq has a CE mark of conformity for its developed diagnostic product to identifying cervical cancer in cytological specimens.
1:52 Serum Apoptotic DNA as Epigenetic Biomarkers for Cancer Detection and Management
Howard Urnovitz, CEO, Chronix Biomedical (www.chronixbiomedical.com)
Next-generation sequencing (NGS) continues to reveal the epigenetic complexities of cancer. Measuring the apoptotic DNA found in serum/plasma with an NGS approach provides for the detection of cancer DNA fingerprints with remarkable accuracy and without prior knowledge of the unique epigenome of the neoplasm. Cancer agnostic molecular diagnostics are critical for personalized medicine approaches for detection and management of all cancers.
2:05 Towards Personalized Medicine: In silico Strategies for the Identification of Biomarker-Guided Combination Therapies
Stephan Brock, Ph.D., CEO, LIFE Biosystems AG (www.lifebiosystems.com)
LIFE's in silico oncology efforts are dedicated to maximizing the clinical success of new and approved oncology drugs. Collaborating with comprehensive cancer centers and biopharma, LIFE is focused on discovering personalized approaches for the early identification and appropriate treatment of non-responsive cancer patients. LIFE has an established strategic relationship with a leading US cancer center, and LIFE's in silico solutions are used to turn personalized patient care into routine operations. Insight about how to use integration of clinical and molecular data for improved clinical decision support will be presented.
2:18 Detecting Breast Cancer Recurrence Early Using Metabolite Profiling
Daniel Raftery, Ph.D., M.B.A., CSO, Matrix Bio, Inc., and Professor of Chemistry, Purdue University (www.matrix-bio.com)
Matrix-Bio is developing advanced metabolite profiles for the detection of cancer at its earliest stages. Blood based small molecule biomarkers are discovered and paneled using a combination of nuclear magnetic resonance and mass spectrometry along with multivariate statistical methods. These profiles can then be ported to high throughput diagnostic platforms and workstations. Matrix-Bio’s first test, VeraMarkerTM-BCR, will provide breast cancer survivors with an improved diagnostic test that is more sensitive than the current breast cancer monitoring blood tests and detects recurrence more than a year earlier than clinical diagnosis, thus providing a new window of opportunity for improved therapies and outcomes.
2:31 Networking Refreshment Break
3:13 RNAscope™, a Novel RNA in situ Hybridization Platform for Companion Diagnostics
Yuling Luo, Ph.D., President & CEO, Advanced Cell Diagnostics, Inc. (www.acdbio.com)
Companion diagnostics exploiting molecular biomarkers is a critical component of personalized medicine. In oncology, most companion diagnostic tests are based on in situ detection of protein or DNA biomarkers using IHC or FISH, respectively. However, in situ detection of RNA has not been recognized as a viable diagnostic platform due to low sensitivity and specificity of current methodologies. As a result, RNA biomarkers are currently analyzed by RT-PCR at the expense of destroying the tissue context, which is often highly heterogeneous in clinical specimens. ACD has developed RNAscope™, the first RNA in situ hybridization platform with single molecule detection sensitivity, enabling rapid development of RNA-based companion diagnostics.
3:26 “Distilling” Personalized Medicine – From Biomarker Discovery to “Time-to-Event Prognostics”
Adam Gouldsworthy, Ph.D., Business Development Manager, CompanDX Ltd. (www.compandx.com)
The paradigm shift offered by targeted therapies exemplifies both the opportunities and challenges for personalizing cancer treatment. CompanDX is a bioinformatics driven biotechnology company, which is responding to the clinical need for improved biomarker discovery and the underlying requirement for a powerful systems biology capability to accurately define multiple phenotypes. We will describe the development and utility of a suite of "Distiller" bioinformatics tools, whose application boundaries stretch from the identification of prognostic and predictive biomarkers to the objective stratification of clinical patients, and from the guiding of therapy decisions to the development of companion diagnostics.
3:39 Deep Understanding of Tumor Molecular Aberrations for Optimizing Cancer Therapy
Gary Palmer, M.D., J.D., Senior Vice President, Medical Affairs & Commercial Development, Foundation Medicine, Inc. (www.foundationmedicine.com)
Cancer research has seen an expansion of available targeted therapies and a detailed molecular mapping of thousands of tumors at cancer genome centers worldwide. It is now becoming technically possible to comprehensively characterize the molecular drivers of cancer in an individual patient. This information, coupled with the growing availability of targeted therapies, could lead to better outcomes for some patients and more efficient allocation of resources in healthcare delivery and drug development. Foundation Medicine, launched by leaders in cancer genomics, cancer biology, clinical oncology and information sciences, is dedicated to helping bring this transformation into routine clinical practice.
3:52 Genes to Products: Translating Tissue Discovered Biomarkers for Colon Cancer to Blood-Based Testing
Lawrence LaPointe, Ph.D., B.Sc., CEO, Clinical Genomics, Pty. Ltd. (www.clinicalgenomics.com)
Clinical Genomics develops assays to improve the early detection of colorectal cancer based on the discovery and validation of gene expression signatures in clinical tissue specimens sensitive for cancer. Our scientists are now translating these tissue discovered biomarkers to blood-based tests. In particular, our molecular diagnostic assays show promise for detection of the earliest, most-treatable stages of this disease including pre-invasive adenomas. A key aspect of our success is our integrated approach to bioinformatics, understanding the source of tumor-derived nucleic acids in blood and assay design. The potential applications of our technologies extend beyond our immediate focus on colon cancer.
4:05 So Many Markers, So Little Tissue™ - A Solution for Personalized Medicine
Jonathan Cohen, President and CEO, 20/20 GeneSystems, Inc. (www.2020gene.com)
20/20 GeneSystems has a patented technology for multiplex biomarker analysis in tissue called L-IHC. We are using L-IHC to develop several companion diagnostics to targeted therapies including SUTENT®, AFFINITOR®, and TORISEL®. 20/20 is also providing services to drug companies using L-IHC. From a single FFPE tissue section we can detect up to 10 proteomic biomarkers while maintaining morphology to allow localized analysis of the section. Analysis is customized and can include TMAs, Multivariate Index Analysis, and proprietary antibodies. Key applications include analysis of signaling pathways in tumors treated with targeted therapies.
4:18 A New Platform for Web-Based Delivery of in vitro Diagnostic Multi-index Assays
Ryan Van Laar, Ph.D., Founder, Research & Development, ChipDX LLC (www.chipdx.com)
ChipDX develops diagnostic and prognostic assays for oncology using public & proprietary datasets. We have developed an advanced Quality Control, DX analysis and reporting system, designed for the Affymetrix GeneChip system. The modular framework system allows other tests to be easily incorporated. ChipDX also develops, validates, compares or refines assays for 3rd party diagnostic companies. We have incorporated the meta-analysis of publicly available genomic datasets with an new online platform to potentially address unmet clinical needs. The system has to potential to standardize genomic analysis on a global scale by providing a universal quality control model and reporting system.
4:31 Partnering Exploration Discussions
6:00 Close of Day
Limited Speaking Slots Available
If you would like to submit a proposal to give a presentation during the opening session, please click here to submit a title and a brief 2-3 sentence summary (maximum of 60 words) of the key points to be covered in the presentation.
Cambridge Healthtech Institute
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